Volunteering for Clinical Trials
Your Guide to Participating in a Research Study

Over the past several years, an increasing number of people have been interested in learning more about clinical research and how to participate in a clinical research study.

This page provides information about the clinical trial process and what it means for you to participate in a clinical trial.

 

What is a clinical trial? 
A clinical trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Clinical trials (also known as medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way of finding treatments that work.

Ideas for clinical trials usually come from researchers. Once researchers test therapies or procedures in the laboratory and get promising results, they begin the clinical trial. New therapies are tested on people only after laboratory and animal studies show promising results.

What protection is there for people who participate in clinical trials? 
The government has strict rules to protect people who choose to participate in clinical trials. These rules are set by the Food and Drug Administration (FDA). The FDA has these rules to make sure that people who agree to be in a clinical trial are treated as safely as possible.

Every clinical trial must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and that the potential benefits outweigh any risks.

An IRB is a group of physicians, community persons and others who are independent from the study and act to assure that a clinical trial is ethical and the rights of study participants are protected. The IRB approves the trial before it is started and reviews data during the study to assure the study is being conducted in the safest manner possible.

What is informed consent? 
Before participating in a clinical trial, the research staff will give you an informed consent form to review. The consent form contains complete information about the trial, including why the research is being done, the purpose of the study and what procedures are involved. In addition, it includes how long your participation will last, possible benefits and risks, other treatments that are available and the fact that you can leave the trial at any time. It is a good idea that you take the consent form home to review and discuss it with family members.

What are the possible risks and benefits involved in clinical trials? 

Benefits

  • Gain access to new treatment not available to the public
  • Take an active role in your health care
  • Obtain expert medical care and close monitoring by research staff
  • Help others by contributing to medical research
  • Receive all study-related procedures and medications at no cost to you or your insurance carrier

Potential Risks

  • Possible side effects from study medications or treatments
  • Additional time commitment for required study visits

How to find out more about clinical trials? 
A good way to find out if there are any clinical trials that may benefit you is to ask your doctor. We at Cardiology Consultants of Philadelphia abide by the standards of good clinical practice and subscribe to the highest of ethical standards. Patient safety is paramount in all of our research endeavors. Talk to your doctor to find out more about the clinical trials being conducted at Cardiology Consultants of Philadelphia.